Crown Family School & Chapin Hall IRB
National Institutes of Health (NIH) single IRB policy
(Effective Date: January 25, 2018)
NIH requires the use of a single IRB (sIRB) of record for the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site (multi-institutional research) in the United States. Research carried out at more than one site where each site is engaged1 in the project is considered a multi-site study. This NIH policy applies to all solicitations issued on or after policy effective date of January 25, 2018.
For all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after the policy effective date where each domestic site will conduct the “same research protocol”2 involving non-exempt human subjects research regardless of the number of NIH awards. For example, if a study involves a separate site for study coordination or coordination of data and statistical analyses and the site is conducting the same protocol as the other participating sites then all sites are expected to rely on the designated single IRB. Visit https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm
This policy applies only to studies where the same protocol study is being conducted at more than one site; it does not apply to studies that involves more than one site but the sites have different roles in carrying out the research.
Awards will not be made without certification of IRB approval; however, in extenuating circumstances the grant award will be made without certification of IRB approval but will include terms and conditions restricting all human subject activities. Once Reliance Authorization Agreements are executed and IRB approval is obtained, the NIH Institute or Center will lift the restrictions by revising the Notice of Award and the award recipient may then start the multi-site research https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.
1 An engaged institution obtains: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; or (4) the lead role for a multi-site project (e.g., primary recipient of a grant).
2 Per NIH, same protocol research studies are protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes. Sites that are accruing research participants for studies that are identical except for variations due to local context consideration would be considered to be conducting the same protocol research study.
This NIH policy applies to all engaged sites that are sub-awards to a primary award recipient or separate awards made to all participating engaged sites.
This NIH policy also applies to delayed-onset awards proposed in applications received after the effective date.
Note: Some research projects are not subject to this NIH policy:
- The NIH policy does not apply to research conducted under career development (K), research training (T), and fellowship (F) awards; and
- The NIH policy does not apply to participating engaged sites that are conducting a “different research protocol.” For more information, visit: https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm
The grant application must include a Single IRB Plan that includes the following:
- A statement that will or has identified a single IRB for all engaged sites and a list of engaged sites willing to rely upon the review of a single IRB. Each site in the multi-site study should agree to a single IRB arrangement prior to the submission of a grant application.
- A statement that future engaged sites will be required to rely on the chosen single IRB of record for the study.
- Communication Plan that describes the coordination of protocol-specific information:
- The responsible party for preparing and submitting the multi-site protocol study including amendments from any Relying Site to the Reviewing IRB.
- The responsible party and timeframe for collecting or providing information on conflict of interest matters from each engaged site;
- The responsible party for collecting or providing information on study team education and training in human subjects research and other relevant training;
- The responsible party for collecting or providing information on local context and individual site requirements that would affect the research study (e.g., special considerations regarding local populations or state laws).
- A statement that the Reviewing IRB Site will enter into a written Reliance Authorization Agreement with each Relying Site.
- A statement on the maintenance of records related to the Communication Plan and Reliance Authorization Agreements.
The funding NIH Institute or Center will either accept the single IRB proposed in a grant application or will work with the award recipient to select an appropriate single IRB at the time of award or prior to the start of the multi-site study.
For delayed-onset awards, prior to the involvement of human subjects in research, the grant recipient submits to the funding NIH Institute or Center a completed section on the protection of human subjects and the Single IRB Plan.
The designated single IRB must be registered with the HHS Office of Human Research
Selection criteria include appropriate expertise, experience and capacity to review the study protocol for all participating sites. Many times a lead institution will be the Single IRB of Record.
Study sponsor or grant Funding Opportunity Announcements may pre-determine the single IRB that will serve as the single IRB.
The Single IRB must be willing to commit to transparency through sharing information, when requested, about the review process.
The policy recognizes that it may not always be possible to use a single IRB, and it provides for exceptions. Per https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-003.html policy, an exception must be included in the NIH grant application and covered under one of the following exceptions:
- Policy-Based Exception: This policy allows exceptions for domestic sites when a federal, state or tribal nation regulation prohibits review by a single IRB. The grant application must cite the legal or local policy and list the specific site(s) affected by the legal or local policy. Other sites not affected by the legal or local policy will rely on the single IRB.
- Time-Limited Exception: For ancillary studies to an ongoing research study, until the parent study is expected (e.g., in a competing renewal application) to comply with the single IRB policy. This exemption must be documented in the Single IRB Plan in the grant application and specify associated parent study.
- Compelling Justification Exception: Provide a rationale for a specific site, which will be reviewed by an Exceptions Review Committee to determine if there is adequate justification to approve an exception. NIH will only consider this exception for proposal/contracts that are in the competitive range.